Clinical Research Associate

Wilmington, Delaware

Posted in Pharmaceuticals
30 days ago

Job Description

At AstraZeneca, we work together across boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. As a Field Based Clinical Research Associate, you'll play a pivotal role in channeling our capabilities to make a positive impact on changing patients' lives.

In this role, you will have the local responsibility for the delivery of the studies at allocated centers and active participants in study team(s). You'll work in close collaboration with other Monitors and the Local Study Delivery Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner.

You will also be responsible for the preparation, initiation, monitoring and closure of an agreed number of centers in clinical studies according to AZ Procedural Documents, international guidelines such as ICH and GCP as well as local regulations.

If you have longer tenure and experience, we may also encourage you to take on additional responsibilities that include additional tasks associated with Lead CRA, Senior CRA and/or Site Liaison.
Minimum Requirements

  • Bachelor's degree, preferably in Life Science or Medical Related field.
  • 2+ years of CRA experience in Oncology, Cardiovascular/Metabolic and or Respiratory therapeutic experience
  • Fluent knowledge of spoken and written English
  • Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP
  • Good knowledge of relevant local regulations
  • Good medical knowledge in relevant AZ Therapeutic Areas
  • Basic understanding of the drug development process
  • Good understanding of Clinical Study Management including monitoring, study drug handling and data management
  • Ability to travel as required, 50-70%
Competencies and Skills
  • Ability to deliver quality according to the requested standards
  • Ability to work in an environment of remote collaborators
  • Handles change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business
  • Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time
  • Excellent written and verbal communication skills, negotiation, teamwork and interpersonal skills
  • Good analytical and problem solving skills
  • Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines
  • Good cultural awareness
  • Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment
  • Team oriented and flexible; ability to respond quickly to shifting demands and opportunities

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